Sr Director, Cell Therapy Clinical Operations

AbelZeta is a clinical stage biopharmaceutical company focused on the development of novel immunotherapy products. We are on a rapid growth trajectory and have a highly energized and accomplished team driving to new frontiers of care for cancer and autoimmune disease patients. 

We are seeking a (Senior) Director, Clinical Operations to join our team. This role will be reporting to the VP of Clinical Development and will provide strategic and operational leadership for the planning, execution, and delivery of clinical trials across AbelZeta’s pipeline. This individual will manage CRO/vendor/site partnerships and ensure high-quality, compliant, and timely conduct of clinical programs. The role requires a hands-on leader and manager who excels at driving operational excellence in a dynamic, fast-paced environment. 

The ideal candidate should have experience in cell and gene therapy, with a solid understanding of autoimmune disease, and a proven track record of leading clinical operations in a clinical-stage company. Strong expertise in managing complex, multifaceted clinical trials is essential for success in this role.

Responsibilities and Duties:

• Provide strategic direction and operational oversight for Phase I/II clinical trials, ensuring alignment with corporate goals and regulatory requirements.
• Develop and implement clinical operations strategies, timelines, budgets, and resource plans for assigned programs.
• Select, negotiate, and manage CROs and external vendors to ensure quality, cost-effectiveness, and adherence to study deliverables.
• Establish strong relationships with Principal Investigators (PIs) and study sites, serving as a key point of contact to ensure effective communication, issue resolution, and high-quality trial conduct.
• Ensure trials are executed in accordance with GCP, FDA, EMA, and other global regulatory requirements; partner with Quality and Regulatory teams to maintain inspection readiness.
• Collaborate closely within Clinical Development and with Regulatory, Translational Medicine, and CMC functions to enable seamless program execution.
• Proactively identify operational risks and issues, implementing mitigation strategies to maintain study timelines and quality.
• Provide regular updates and recommendations to senior leadership on program progress, risks, and resource needs.
• Other duties as assigned.

Qualifications and Requirements:

• Advanced degree (MS, PharmD) in life sciences or related field preferred; or Bachelor’s degree with extensive experience considered.
• 12 years of experience in clinical operations, with at least 6 years in leadership roles in biotech/pharmaceutical settings.
• Proven track record in successfully leading global Phase I/II trials
• Strong understanding of regulatory guidelines (GCP, FDA, EMA).
• Demonstrated ability to manage CROs/vendors and complex budgets.
• Excellent leadership, communication, and decision-making skills.
• Ability to thrive in a fast-paced, entrepreneurial environment with shifting priorities.  

Why You Should Join AbelZeta

• Join a high-growth and fast-paced organization.
• Defined career path and annual performance review and feedback process.
• Comprehensive Benefits Plan, including 100% company paid medical, dental, vision, life Insurance, short-term and long-term disability insurance, and more!
• Competitive company 401k match.
• Paid holidays, sick leave, and annual leave.

AbelZeta is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. AbelZeta validates right to work using E-Verify. Salary at AbelZeta is determined by various factors, including but not limited to location, the individual’s particular combination of education, knowledge, skills, competencies, and experience, as well as contract-specific affordability and organizational requirements. The estimate displayed represents the typical salary range for this position and is just one component of AbelZeta’s total compensation package for employees.